{"id":573,"date":"2016-02-11T19:48:24","date_gmt":"2016-02-11T19:48:24","guid":{"rendered":"https:\/\/awrightpath.net\/?p=573"},"modified":"2019-06-05T19:49:39","modified_gmt":"2019-06-05T19:49:39","slug":"announcing-final-guidance-document-submission-and-review-of-sterility-information-in-premarket-notification-510k-submissions-for-devices-labeled-as-sterile-webinar-february-11","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/announcing-final-guidance-document-submission-and-review-of-sterility-information-in-premarket-notification-510k-submissions-for-devices-labeled-as-sterile-webinar-february-11\/","title":{"rendered":"Announcing Final Guidance Document: ?Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile? ? Webinar February 11, 2016"},"content":{"rendered":"\n

Today, the U.S. Food and Drug Administration issued final guidance document, ?Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile? <\/a>.  Its recommendations seek to ensure that manufacturers incorporate adequate sterilization methods for 510(k) devices labeled as sterile and provide appropriate documentation and information to the FDA for premarket review for established and novel sterilization processes. This final guidance also provides additional details about the pyrogenicity testing information that sponsors should include in a 510(k) submission for certain sterile devices and those labeled as non-pyrogenic. Novel sterilization methods are newly developed and, therefore, have little information on their effectiveness. The Sterility Final Guidance describes measures to enhance oversight of 510(k) submissions that incorporate these sterilization methods, specifically:<\/p>\n\n\n\n